BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1882224 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11963
    Event Type
    Death
    Date Received
    October 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. WE HAVE NO INFORMATION FROM A HEALTH CARE PROFESSIONAL TO SUGGEST THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    ATTORNEY ALLEGED PATIENT "IMPLANTED WITH A MEDTRONIC SPRINT FIDELIS LEAD WIRE SYSTEM, AND SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." FURTHER ALLEGES PATIENT DIED AS A DIRECT AND PROXIMATE RESULT OF DEFECTS" IN SPRINT FIDELIS LEAD. IT WAS PREVIOUSLY REPORTED LEAD WAS REPLACED DUE TO OVERSENSING, INAPPROPRIATE THERAPIES, SHOCKED 18 TIMES, AND FRACTURE. PATIENT HAD REPORTED LEAD AND DEVICE WERE REPLACED DUE TO "IT WENT BAD." REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DID NOT HAVE THE SPRINT FIDELIS LEAD MODEL IMPLANTED AT TIME OF DEATH. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death